Food safety law challenge for FDA

FSMA regulations also offer enormous opportunities to assure U.S. consumers of a safe food supply.
FSMA focuses much of its effort on food-borne illness prevention and much of the burden will shift to industry.
FDA was not provided additional resources to implement FSMA.

Implementing the Food Safety Modernization Act (FMSA) not only presents tremendous challenges to the Food and Drug Administration, but the new regulations also offer enormous opportunities to assure U.S. consumers of a safe food supply.

Capt. Catherine Vieweg, director of the compliance branch of the FDA Southwest Import District Department (SWID), discussed the challenges facing the agency as it begins the process of administering these new regulations at the recent Texas Produce Association’s annual conference at South Padre Island.

Vieweg’s group covers the entire U.S. Mexican border and 40 percent of the food imported into the United States every year.

“FSMA includes a large component focusing on imported food,” she says. That’s a crucial aspect of the program since more than 15 percent of the U.S. food supply is now imported. A much larger percentage of fruits and vegetables are imports.

Vieweg says FSMA focuses much of its effort on food-borne illness prevention and much of the burden will shift to industry. “FSMA emphasizes the importance of industry taking on more responsibility. We also have a goal of assuring that foreign food is as safe as domestic.”

She says importers must “know their supply chains and gain confidence in them.”

Implementing those new regulations comes with large challenges.

A lack of designated funding for implementation, as well as the number of new rules to be put into place, are among crucial issues facing the FDA as it rolls out the new FMSA regs in the first three years of the program, Vieweg says.

“This act has enormous potential to improve food safety for the country,” she says. “FDA has been asking for various authorities included in FSMA for years. We are excited to finally have them. It will take a Herculean effort to apply this act.”

Funding will be another matter. “FDA was not provided additional resources to implement FSMA,” she says. “But, we will find a way to do it — it’s too important not to do so.”

She says the number of new regulations included in the act also pose challenges. “We have approximately 50 different regulations we need to push out the first three years. We are committed to making those timelines.” January, 2013 is the deadline for FSMA implementation.

Vieweg says FDA will tap various agency components — field staff, headquarters, policy and others — to coordinate and implement the regulations.

“We are interested in hearing from industry on how we can make this program work,” she says. “We are engaged in an enormous amount of outreach. We are excited to have this new authority, and FDA is committed to making it work.”